MAUDE Adverse Event Report: WUS TECH (VIETNAM) CO., LTD DRIVE; POWER MOBILITY

Model Number	VENTURA420CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4) is the initial importer of the device which is a power scooter.Scooter was returned and evaluated as conforming.She was "flung" forward the first time she was using the unit when she adjusted the tiller.(steering).She hit her head.The weight maximum on the unit is 400 pounds.We are filing this report per protocols because she hit her head.

• Brand Name: DRIVE
• Common Device Name: POWER MOBILITY
• Manufacturer (Section D): WUS TECH (VIETNAM) CO., LTD; no.31, vsip ii, road 6,; hoa phu ward,; thu dau mot, binh duong ; VM
• MDR Report Key: 9984923
• Report Number: 3007963811-2020-00001
• Device Sequence Number: 11911403
• Product Code: INI
• UDI-Device Identifier: 00822383294025
• UDI-Public: 822383294025
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/11/2020
• Report Date (Section F): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: VENTURA420CS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2020
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 03/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 181
• Date Report Sent to FDA: 03/11/2020